WARRIOR Ancillary Study for CCTA Analysis

NCT05035056 | Completed

• 2 other identifiers: STUDY000008961R01HL151266
• Study Type: observational
• Target: 191
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, quantitative characterization of plaque using coronary computed tomographic angiography (CTA) will be used to determine if women who were treated with intensive medical therapy have a greater reduction in the amount and type of cholesterol plaque compared to women receiving usual care and if this results in beneficial changes in clinical symptoms. The study will provide an understanding of how intensive medical therapy works in providing clinical benefit in women with nonobstructive plaque.

Conditions

Coronary Artery Disease; Ischemia; Non-Obstructive Coronary Atherosclerosis

Outcome Measures

Primary Outcomes (3)

• Change in atherosclerotic plaque burden and noncalcified plaque composition

  Change in atherosclerotic plaque burden (%) and noncalcified plaque composition (%) using Autoplaque plaque analysis software

  3 years

• Change in coronary plaque inflammation (measured as CT attenuation of Pericoronary adipose tissue)

  Change in pericoronary artery adipose tissue (PCAT) density (CT attenuation of PCAT, in Hounsfield Units) by Autoplaque plaque analysis software

  3 years

• Change in angina score assessed by the Seattle Angina Questionnaire (SAQ)

  Change in angina score quantified by the Seattle Angina Questionnaire (SAQ)

  3 years

Study Arms (1)

CT Coronary Angiogram with quantitative characterization of plaque

Participants (102) from Intensive Medical Therapy \[IMT\] and 102 from the Usual Care \[UC\] group in the WARRIOR trial) will undergo CTA at the Year 3 follow-up visit (can be as early as 2 years from randomization) at their respective enrollment study sites. Quantitative characterization of plaque analysis will be conducted at Cedars-Sinai Medical Center using Autoplaque plaque analysis software.

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This ancillary sub-study will draw 204 patients from the WARRIOR patient group (4422 women), who have undergone a baseline CTA as part of the WARRIOR trial. From this group, 204 patients most compliant with the medication regimen (intensive medical therapy (IMT) with aspirin, statin, angiotensin-converting enzyme inhibitor, and/or angiotensin receptor blocker) vs. usual care (UC) recommended in their treatment groups will undergo a follow-up coronary CTA.

You may qualify if:

• Initial CTA with excellent or good image quality-defined as images where we are able to clearly identify the atherosclerotic plaque. Based on our preliminary assessment, we expect 90% of studies to be included.
• Measurable plaque with total plaque volume \>0mm3; women without significant plaque will not receive additional radiation, and we can detect measurable changes in plaque burden and plaque composition.

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Related Publications (1)

• Tamarappoo B, Wolny R, Tomasino GF, Berman D, Handberg E, Pepine CJ, Lo MC, Budoff M, Shaw L, Shufelt C, Wei J, Gulati M, Merz CNB, Dey D. Design and rationale of the WARRIOR ancillary study for coronary CT angiographic analysis. Am Heart J. 2026 Apr;294:107340. doi: 10.1016/j.ahj.2026.107340. Epub 2026 Jan 2.

  PMID: 41485680 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Ischemia

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Damini Dey, PhD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

• Balaji Tamarappoo, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Scientist, Director of Quantitative Image Analysis, Biomedical Imagng Research Institute

Study Record Dates

• First Submitted: August 20, 2021
• First Posted: September 5, 2021
• Study Start: July 1, 2020
• Primary Completion: May 2, 2025
• Study Completion: January 31, 2026
• Last Updated: March 19, 2026

Record last verified: 2026-03

Locations

US (1)